Mobile app for reducing stress in people with depression

A Randomized Control Trial to Investigate the Effectiveness of Smart Mental Health Interventions for Stress Reduction(inMind) During the Pharmacological Treatment in Mild to Moderate Major Depressive Disorder.

This study is testing a mobile app that helps reduce stress for people with mild to moderate depression to see if it makes them feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 19 Years to 65 Years
• Sex: All
• Sponsor: Korea University Guro Hospital (other)
• Locations: 1 site (Seoul, Guro Gu)
• Trial ID: NCT05312203 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a mobile application designed to alleviate stress in individuals diagnosed with mild to moderate major depressive disorder. It employs a single-blind, multicenter, randomized, controlled crossover design, where participants will use the app for four weeks followed by a waitlist period. The app incorporates mindfulness-based stress reduction, cognitive-behavioral therapy techniques, and relaxation sounds to provide integrated interventions. Participants will be recruited from three university hospitals in South Korea and will be assessed for their depression levels using the Hamilton Rating Scale.

Who should consider this trial

Good fit: Ideal candidates are adults aged 19-65 diagnosed with mild to moderate major depressive disorder.

Not a fit: Patients with severe major depressive disorder or other significant mental health disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this app could provide an accessible and effective tool for managing stress and improving mental health in patients with depression.

How similar studies have performed: Other studies have shown promise in using mobile health applications for mental health interventions, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Adults between the ages of 19 and 65;
2. Diagnosed with mild to moderate major depressive disorders in an expert interview evaluation according to the DSM-IV diagnostic criteria (Score of 7-24 on the Hamilton Rating Scale for Depression \[HAM-D\]);
3. Stable medication for 28 days prior to study participation;
4. Informed consent and voluntary participation.

Exclusion Criteria:

1. Hard to use smart phone or unable to independently use Application;
2. Diagnosed with severe major depressive disorder in an expert interview evaluation according to the DSM-5 diagnostic criteria (score of 25 or more on HAM-D);
3. Severe mental disorders (current or in the past), including Major depressive disorder with psychotic features, bipolar affective disorder, personality disorder, obsessive compulsive disorder, autism spectrum disorder, substance use disorder;
4. History of brain injury, epileptic seizures, intellectual disability, or cognitive disorders;
5. History of severe physical disorders, including cancer, tuberculosis, severe cardiovascular disease, etc.
6. Individuals participating in other cognitive behavioral therapy or activities related to stress relief

Where this trial is running

Seoul, Guro Gu

• Department of Psychiatry, Korea University Guro Hospital — Seoul, Guro Gu, Korea, Republic of (RECRUITING)

Study contacts

• Principal investigator: Junhyung Kim, MD, PhD — Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine
• Study coordinator: Junhyung Kim, MD, PhD

Conditions: Major Depressive Disorder, Stress, Major depressive disorders, Mobile health, Mindfulness-based intervention, Cognitive-behavior therapy, Relaxation Therapy, Cost-effectiveness